"Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by the Food and Drug Administration (FDA).
- Patient Information:
Details with Side Effects
Provide the following information to the vaccine recipient or guardian:
- Inform of the potential benefits and risks of immunization with FLUARIX.
- Educate regarding potential side effects, emphasizing that: (1) FLUARIX contains non-infectious killed viruses and cannot cause influenza and (2) FLUARIX is intended to provide protection against illness due to influenza viruses only, and cannot provide protection against all respiratory illness.
- Instruct to report any adverse events to their healthcare provider.
- Inform that safety and efficacy have not been established in pregnant women. Register women who receive FLUARIX while pregnant in the pregnancy registry by calling 1-888-452-9622.
- Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
- Instruct that annual revaccination is recommended.
Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Fluarix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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